OncoMatch/Clinical Trials/NCT07775287
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)
Is NCT07775287 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for colorectal cancer.
Treatment: Petosemtamab · Cetuximab · Bevacizumab · 5-FU · Leucovorin (Calcium Folinate) · Oxaliplatin · Irinotecan — The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer that has recurred after previous treatment and that cannot be safely removed by surgery or has spread to other parts of the body. Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or doctor's choice of standard-of-care (SOC) cetuximab or bevacizumab + chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Must have documented KRAS and NRAS wt CRC, as determined by medical record of results from local testing or as assessed by central testing. Next-generation sequencing-based test results from tumor tissue are required for determining eligibility. At a minimum, local testing must have assessed the mutational status of KRAS and NRAS G12/G13, A59, Q61, K117, and A146 codons.
Required: NRAS wild-type
Must have documented KRAS and NRAS wt CRC, as determined by medical record of results from local testing or as assessed by central testing. Next-generation sequencing-based test results from tumor tissue are required for determining eligibility. At a minimum, local testing must have assessed the mutational status of KRAS and NRAS G12/G13, A59, Q61, K117, and A146 codons.
Excluded: BRAF v600 mutation
BRAF V600 mutation (eg, V600E)
Excluded: HRAS activating mutation
known documented activating HRAS mutation identified prior to enrollment from local testing results in the medical record, if available
Excluded: HER2 (ERBB2) positive/amplified
ERBB2/human epidermal growth factor receptor 2 (HER2) positive/amplified tumor status
Excluded: MSI high
microsatellite instability-high/deficient mismatch repair tumor status
Excluded: MMR deficient
microsatellite instability-high/deficient mismatch repair tumor status
Excluded: DPYD homozygous/compound heterozygous variants associated with complete loss of dpd activity
known homozygous/compound heterozygous dihydropyrimidine dehydrogenase gene (DPYD) variants associated with complete loss of DPD activity
Excluded: DPYD complete dpd deficiency
Known complete dihydropyrimidine dehydrogenase (DPD) deficiency
Excluded: UGT1A1 homozygous for the ugt1a1*28 or *6 alleles or compound or double heterozygous for the ugt1a1*28 and *6 alleles
known to be homozygous for the uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1)*28 or *6 alleles or compound or double heterozygous for the UGT1A1*28 and *6 alleles
Prior therapy
Must have received: systemic therapy for unresectable or metastatic CRC — unresectable or metastatic CRC
Has received no more than 1 line of prior systemic therapy for unresectable or metastatic CRC, with documented disease progression. First line (1L) regimen must be fluoropyrimidine- and oxaliplatin- (if 2L choice of backbone is FOLFIRI) or irinotecan- (if 2L choice of backbone is fluorouracil + leucovorin (calcium folinate) + oxaliplatin [FOLFOX]) based. Prior anti-vascular endothelial growth factor receptor (VEGF) treatment is allowed.
Cannot have received: EGFR-targeted therapy
Prior exposure to any agents that target epidermal growth factor receptor (EGFR) (including but not limited to protein products, monoclonal antibodies, tyrosine kinase inhibitors, or antisense oligonucleotide therapy).
Cannot have received: irinotecan in the metastatic setting (irinotecan)
Prior exposure to irinotecan (for participants assigned to FOLFIRI) ... in the metastatic setting.
Cannot have received: oxaliplatin in the metastatic setting (oxaliplatin)
Prior exposure to ... oxaliplatin (for participants assigned to FOLFOX) in the metastatic setting.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07775287 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR-targeted therapy, irinotecan in the metastatic setting, oxaliplatin in the metastatic setting disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Are patients with BRAF alterations eligible?
No. BRAF v600 mutation is an exclusion criterion.
Are patients with HRAS alterations eligible?
No. HRAS activating mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages